Pulmonary Air LeaksVASTNCT02382614
Spiration Valves Against Standard Therapy
A study testing Spiration Valve System in people with Pulmonary Air Leaks, run by Olympus Corporation of the Americas at 20 sites in United States.
Trial summary
VAST is a multicenter, prospective, randomized, controlled study designed to evaluate treatment of persistent air leak with the SVS as compared to standard chest tube drainage management and other standard-of-care interventions in the control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Air Leaks
- What is being tested?
- Spiration Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 20 sitesUnited States
- Study dates
- May 2015to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has an air leak ≥ 100 mL/min, as measured by a digital thoracic drainage system (DTDS)
- Subject has air leak present on at least the 5th day following origination.
Who cannot join
- Subject has air leak only on forced exhalation or cough
- Subject has sepsis
- Subject has pneumonia
- Subject has Acute Respiratory Distress Syndrome (ARDS)
- Subject is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures
- Subject has undergone a bone marrow transplant
- Subject has a primary pneumothorax
- Subject has undergone a prior intervention (including pleurodesis, surgery, blood patch, and pneumoperitoneum) or valve placement.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of Maryland
Baltimore, Maryland, 21201
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
Cooper University Hospital
Camden, New Jersey, 08103
The Christ Hospital
Cincinnati, Ohio, 45219
University of Cincinnati
Cincinnati, Ohio, 45219
University of Texas Southwestern
Dallas, Texas, 75390
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901
Dartmouth Mary Hitchcock Memorial Hospital
Hanover, New Hampshire, 03755
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
El Camino Hospital
Mountain View, California, 94040
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Olathe Medical Center
Olathe, Kansas, 66061
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Mayo Clinic Rochester
Rochester, Minnesota, 55902
California Pacific Medical Center
San Francisco, California, 94115
Swedish Medical Center
Seattle, Washington, Jed Gorden
Southern Illinois University
Springfield, Illinois, 62794
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Safety and Effectiveness of the Spiration Valve System (SVS) in Air Leaks
VAST is a multicenter, prospective, randomized, controlled study designed to evaluate treatment of persistent air leak with the SVS as compared to standard chest tube drainage management and other standard-of-care interventions in the control group. Eligible subjects will be randomized to receive either Spiration Valves (investigational arm) or continue standard-of-care treatment (control arm). Once the air leak has resolved, Spiration Valves should be removed.
- Conditions
- Pulmonary Air Leaks
- Being tested
- Spiration Valve System
- Keywords
- Endobronchial Valve, Minimally Invasive, Intrabronchial Valves, Digital Thoracic Drainage System, Spiration Valve System, Prolonged Air Leak, Persistent Air Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiration Valve SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Spiration Valve System | Experimental | The treatment group will have valves deployed to achieve leak isolation. Receives: Device: Spiration Valve System |
| Medical Management | No intervention | The control group for this study will receive standard chest tube drainage management and standard-of-care interventions. This group will be evaluated and followed in the same manner as the treatment group, but without having valves placed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Air Leak Cessation
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2022
- Study completionFeb 2022
Why it stopped: business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Air LeaksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Corporation of the Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382614
- Sponsor's protocol ID
- 13
- Acronym
- VAST
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2015
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of the Spiration Valve System (SVS) in Air Leaks
- ClinicalTrials.gov ID
- NCT02382614
- Acronym / sponsor ID
- VAST / 13
- Conditions
- Pulmonary Air Leaks
- Keywords
- Endobronchial Valve, Minimally Invasive, Intrabronchial Valves, Digital Thoracic Drainage System, Spiration Valve System, Prolonged Air Leak, Persistent Air Leak
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: business reasons
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Olympus Corporation of the AmericasIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Feb 2022 (actual)
- Study completion
- Feb 2022 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
VAST is a multicenter, prospective, randomized, controlled study designed to evaluate treatment of persistent air leak with the SVS as compared to standard chest tube drainage management and other standard-of-care interventions in the control group. Eligible subjects will be randomized to receive either Spiration Valves (investigational arm) or continue standard-of-care treatment (control arm). Once the air leak has resolved, Spiration Valves should be removed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spiration Valve System | Experimental | Device: Spiration Valve SystemThe treatment group will have valves deployed to achieve leak isolation. |
| Medical Management | No intervention | –The control group for this study will receive standard chest tube drainage management and standard-of-care interventions. This group will be evaluated and followed in the same manner as the treatment group, but without having valves placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has an air leak ≥ 100 mL/min, as measured by a digital thoracic drainage system (DTDS)
- Subject has air leak present on at least the 5th day following origination.
Key exclusion criteria (8 listed)
- Subject has air leak only on forced exhalation or cough
- Subject has sepsis
- Subject has pneumonia
- Subject has Acute Respiratory Distress Syndrome (ARDS)
- Subject is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spiration Valve System | Device | Spiration Valve System |
Primary outcome
Time to Air Leak Cessation
Time frame: Two weeks
Results and safety
The study was stopped early (reason given: business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spiration Valve System in people with Pulmonary Air Leaks, run by Olympus Corporation of the Americas at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: business reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Air Leak Cessation (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.